K091734 is an FDA 510(k) clearance for the SONIC SHOT GX. This device is classified as a Injector, Contrast Medium, Automatic (Class II - Special Controls, product code IZQ).
Submitted by Nemoto Kyorindo Co., Ltd. (Kawaguchi-Shi, Saitama, JP). The FDA issued a Cleared decision on May 21, 2010, 344 days after receiving the submission on June 11, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K091734 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2009 |
| Decision Date | May 21, 2010 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZQ - Injector, Contrast Medium, Automatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |